24 Participants Needed

Lifestyle Changes for Pancreatic Cancer Risk Reduction

(PANTHER-PIC Trial)

JP
Overseen ByJennifer Permuth, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for reducing pancreatic cancer risk?

Research suggests that physical activity and lifestyle changes can help reduce the risk of pancreatic cancer by lowering body weight, improving insulin sensitivity (how well the body uses insulin), and decreasing inflammation. Studies have shown that consistent physical activity over time may slightly lower the risk of developing pancreatic cancer.12345

Is it safe for humans to participate in lifestyle changes like diet and exercise for reducing pancreatic cancer risk?

Research on diet and exercise interventions in pancreatic cancer patients shows that these lifestyle changes are generally safe, with studies focusing on adherence and adverse events during exercise programs. While the studies vary in design and outcomes, they do not report significant safety concerns for humans.25678

How does the treatment of lifestyle changes for pancreatic cancer risk reduction differ from other treatments?

This treatment focuses on modifying lifestyle factors like diet and physical activity to reduce the risk of pancreatic cancer, unlike traditional treatments such as surgery or chemotherapy, which are used after the disease has developed. By addressing modifiable risk factors like obesity and physical inactivity, this approach aims to prevent the disease before it starts.1291011

What is the purpose of this trial?

The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.

Research Team

SM

Shaffer Mok, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals at risk of pancreatic cancer, specifically PDAC. It's designed to see if lifestyle changes like increased physical activity and improved nutrition can help reduce their risk. Details on who exactly can join are not provided, but typically participants would need to meet certain health criteria.

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to 25 kg/m2
I am able to get out of my bed or chair and move around.
My pancreatic growth is confirmed and larger than 15 mm.
See 2 more

Exclusion Criteria

Screen failure for exercise safety
My condition involves high-risk pancreatic cysts or cancer.
I do not have unstable heart or lung conditions.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants engage in a lifestyle intervention involving 150 minutes/week of moderate to vigorous physical activity and nutritional counseling following a Mediterranean diet.

24 weeks
Regular self-monitoring and counseling appointments

Follow-up

Participants are monitored for retention, adherence, and acceptability of lifestyle modifications.

4 weeks

Treatment Details

Interventions

  • Nutrition
  • Physical Activity
Trial Overview The study is testing whether a combination of regular physical activity (PA) and nutritional guidance (N) can positively impact the health outcomes of those at elevated risk for pancreatic ductal adenocarcinoma (PDAC).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Physical Activity (PA) and Nutrition (N)Experimental Treatment2 Interventions
Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit device. Nutrition: Participants will undergo counseling appointments to address nutritional symptoms and will be given targets for daily calorie and protein intake following a Mediterranean diet.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Miles for Moffitt

Collaborator

Trials
1
Recruited
20+

Findings from Research

An updated meta-analysis of 30 studies involving 10,501 pancreatic cancer cases found a weak but statistically significant reduction in pancreatic cancer risk associated with high levels of physical activity, with a relative risk of 0.93.
The analysis suggested that consistent physical activity over time may offer a greater protective effect against pancreatic cancer (RR 0.86) compared to recent or distant past activity, although the overall association remains weak and is not influenced by smoking status or body mass index.
Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis.Behrens, G., Jochem, C., Schmid, D., et al.[2022]
Increased physical activity (PA) significantly reduced systemic inflammatory cytokines in overweight and obese individuals, suggesting a potential mechanism for preventing obesity-related pancreatic ductal adenocarcinoma (PDAC).
In pre-clinical models, PA combined with dietary changes delayed weight gain and reduced PDAC incidence, indicating that lifestyle interventions may help prevent PDAC in high-risk obese individuals, although weight loss alone did not prevent tumor growth in certain models.
Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation.Pita-Grisanti, V., Dubay, K., Lahooti, A., et al.[2023]
A 12-week multimodal lifestyle intervention for a 55-year-old woman with advanced pancreatic cancer was found to be safe and feasible, showing significant improvements in body weight and physical fitness.
The intervention also led to reductions in psychological distress, anxiety, and depression, suggesting that integrated supportive care can effectively manage symptoms of metastatic cancer and cachexia.
Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report.Avancini, A., Trestini, I., Tregnago, D., et al.[2023]

References

Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis. [2022]
Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation. [2023]
Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report. [2023]
Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. [2023]
Can physical activity modulate pancreatic cancer risk? a systematic review and meta-analysis. [2018]
Physical activity, diet, and pancreatic cancer: a population-based, case-control study in Minnesota. [2022]
Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. [2022]
Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. [2023]
A review of lifestyle and environment risk factors for pancreatic cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Physical activity and pancreatic cancer risk: a systematic review. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Obesity, recreational physical activity, and risk of pancreatic cancer in a large U.S. Cohort. [2005]
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